MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM 18239 USA1-D001-MG-USA1 manufactured by Insulet Corporation.

Event Text Entries

[187072275] The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported er visit and hyperglycemia. No lot release records were reviewed, as the product lot number was not provided.? Living with diabetes.?? Chapter 13 / page 172-173.? Warning: keep an emergency kit with you at all times to quickly respond to any diabetes emergency.? Prepare an emergency kit to keep with you at all times. The kit should include: several new, sealed pods.? A vial of rapid-acting u-100 insulin (see "general warnings" on page xii for? Insulins cleared for use in the? Omnipod? Dash? System). Syringes or pens for injecting insulin.? Blood glucose test strips.? Blood glucose meter.? Ketone test strips.? Lancing device and lancets.? Glucose tablets or another fast-acting source of carbohydrate.? Alcohol prep swabs.? Instructions from your healthcare provider about how much insulin to inject if delivery from the pod is interrupted.? A signed letter from your healthcare provider explaining that you need to carry insulin supplies and the? Omnipod? Dash? System.? Phone numbers for your healthcare provider and/or physician in case of an emergency.? Glucagon kit and written instructions for giving an injection if you are unconscious. (see "avoid lows, highs, and dka" on page 176).? Living with diabetes.?? Chapter 13 / page 176.? Avoid lows, highs, and dka.? You can avoid most risks related to using the? Omnipod? Dash? System by practicing proper techniques and by acting promptly at the first sign of hypoglycemia, hyperglycemia, or diabetic ketoacidosis. The easiest and most reliable way to avoid these conditions is to check your blood glucose often.
Patient Sequence No: 1, Text Type: N, H10

[187072276] It was reported that patient sought medical attention due to the fact that personal diabetes manager (pdm) would not deliver a bolus for several hours. Patient's mother reported the following: earlier that day at school, patient canceled a meal bolus after requesting too many units before lunch; mother went to school and gave manual injection. Patient's blood glucose (bg) levels were still running high after school so another manual injection was delivered. At 9:00pm, the pdm still wouldn't delivered a bolus and patient's bg levels had climbed to 350 mg/dl. Mother was concerned and took patient to the emergency room, where a urinalysis test was run and patient was diagnosed with hyperglycemia (over 1000 mg/dl). Patient was treated with a saline drip and insulin injection, tested negative for ketones and was sent home after 3-4 hours. Patient was given a prescription for tramadol (50mg) for menstrual cramping as well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3004464228-2020-04717
MDR Report Key9908733
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-04
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJORDAN BISWURM
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal01720
Manufacturer Phone9786007000
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal Code01720
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeLZG
Date Received2020-03-31
Model Number18239
Catalog NumberUSA1-D001-MG-USA1
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address100 NAGOG PARK ACTON MA 01720 US 01720


Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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